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The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study (SLuMBER)

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ClinicalTrials.gov Identifier: NCT02787577
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief Summary:
Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Sleep Lengthening Not Applicable

Detailed Description:

Research Questions

  • Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?
  • What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?

Hypothesis

- Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Aims

  • To assess the feasibility of improving sleep duration and/or quality in habitually short sleepers using behavioural approaches and public health messages targeting sleep hygiene.
  • To identify how improved sleep duration and/or quality affect energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Objectives

  1. To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.
  2. To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.
  3. To assess the feasibility and effectiveness of the intervention.
  4. To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.
  5. To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.
  6. To run the statistical analysis both on an intention-to-treat basis as well as per-protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Sleep Lengthening
The intervention group will receive a personalised sleep consultation session to lengthen sleep by 1-1.5 hours per night by targeting sleep hygiene using behaviour change techniques for 4 weeks.
Behavioral: Sleep Lengthening
Behaviour change techniques targeting sleep hygiene

No Intervention: Control
The control group will be asked to resume their normal lifestyle.



Primary Outcome Measures :
  1. Sleep Duration [ Time Frame: baseline ]
    Wrist Actigraphy

  2. Sleep Duration [ Time Frame: week 4 ]
    Wrist Actigraphy

  3. Sleep Quality [ Time Frame: baseline ]
    Wrist Actigraphy

  4. Sleep Quality [ Time Frame: week 4 ]
    Wrist Actigraphy


Secondary Outcome Measures :
  1. BMI [ Time Frame: baseline ]
  2. BMI [ Time Frame: day 28 ]
  3. Body fat percentage [ Time Frame: baseline ]
  4. Body fat percentage [ Time Frame: day 28 ]
  5. Blood pressure [ Time Frame: baseline ]
  6. Blood pressure [ Time Frame: day 28 ]
  7. Fasting blood glucose [ Time Frame: baseline ]
  8. Fasting blood glucose [ Time Frame: day 28 ]
  9. Fasting total cholesterol [ Time Frame: baseline ]
  10. Fasting HDL cholesterol [ Time Frame: baseline ]
  11. Fasting LDL cholesterol [ Time Frame: baseline ]
  12. Fasting triglycerides [ Time Frame: baseline ]
  13. Fasting total cholesterol [ Time Frame: day 28 ]
  14. Fasting HDL cholesterol [ Time Frame: day 28 ]
  15. Fasting LDL cholesterol [ Time Frame: day 28 ]
  16. Fasting triglycerides [ Time Frame: day 28 ]
  17. plasma leptin [ Time Frame: baseline ]
  18. plasma leptin [ Time Frame: day 28 ]
  19. plasma ghrelin [ Time Frame: baseline ]
  20. plasma ghrelin [ Time Frame: day 28 ]
  21. plasma insulin [ Time Frame: baseline ]
  22. plasma insulin [ Time Frame: day 28 ]
  23. plasma cortisol [ Time Frame: baseline ]
  24. plasma cortisol [ Time Frame: day 28 ]
  25. Homeostasis model assessment estimated insulin resistance (HOMA-IR) [ Time Frame: baseline ]
  26. Homeostasis model assessment estimated insulin resistance (HOMA-IR) [ Time Frame: day 28 ]
  27. Waist circumference [ Time Frame: baseline ]
  28. Waist circumference [ Time Frame: day 28 ]
  29. Hip circumference [ Time Frame: baseline ]
  30. Hip circumference [ Time Frame: day 28 ]
  31. Lean body mass [ Time Frame: baseline ]
  32. Lean body mass [ Time Frame: day 28 ]
  33. Digital volume pulse - Stiffness Index (SI) [ Time Frame: baseline ]
  34. Digital volume pulse - Stiffness Index (SI) [ Time Frame: day 28 ]
  35. Digital volume pulse - Reflection Index (RI) [ Time Frame: baseline ]
  36. Digital volume pulse - Reflection Index (RI) [ Time Frame: day 28 ]
  37. Mnemonic Similarity Test (MST) [ Time Frame: baseline ]
  38. Mnemonic Similarity Test (MST) [ Time Frame: day 28 ]
  39. Dietary Intake (7-day food diary) [ Time Frame: baseline ]
  40. Dietary Intake (7-day food diary) [ Time Frame: week 4 ]
  41. Resting Metabolic Rate (RMR) [ Time Frame: baseline ]
  42. Resting Metabolic Rate (RMR) [ Time Frame: day 28 ]
  43. Total Energy Expenditure (TEE) [ Time Frame: baseline ]
  44. Total Energy Expenditure (TEE) [ Time Frame: day 21-23 ]
  45. Urinary 6-sulphatoxymelatonin [ Time Frame: baseline ]
    Analysed from spot urine sample

  46. Urinary 6-sulphatoxymelatonin [ Time Frame: day 28 ]
    Analysed from spot urine sample

  47. Recent Physical Activity Questionnaire (RPAQ) [ Time Frame: baseline ]
  48. Recent Physical Activity Questionnaire (RPAQ) [ Time Frame: day 28 ]
  49. Sleep Hygiene Index (SHI) [ Time Frame: baseline ]
  50. Sleep Hygiene Index (SHI) [ Time Frame: day 28 ]
  51. Eating Choices Index (ECI) [ Time Frame: baseline ]
  52. Eating Choices Index (ECI) [ Time Frame: day 28 ]
  53. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline ]
  54. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: day 28 ]

Other Outcome Measures:
  1. Dutch Eating Behaviour Questionnaire (DEBQ) [ Time Frame: baseline ]
  2. Women's Health Questionnaire [ Time Frame: baseline ]
    Questionnaire to identify menstrual phase

  3. Women's Health Questionnaire [ Time Frame: day 21 ]
    Questionnaire to identify menstrual phase



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults (18-64 years)
  • Habitually short sleepers (5-<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
  • BMI: 18.5 - <30

Exclusion Criteria:

  • Diagnosed medical conditions such as:
  • Cardiovascular disease
  • Type 1 or Type 2 Diabetes Mellitus
  • Cancer (excluding basal carcinoma) in the past five years
  • Chronic renal or liver disease
  • Inflammatory bowel disease
  • Hypo/hyperthyroidism
  • Sleep conditions:
  • Chronic use of sleeping aid medication
  • Insomnia (Insomnia Severity Index - ISI Questionnaire)
  • Sleep apnoea (Berlin Questionnaire)
  • Extreme Chronotype (HorneOstberg questionnaire)
  • Pregnancy or lactation
  • Weight change of >3 kg in the previous two months
  • Previous or current high alcohol intake (>28 units/week for males and >21 units/week for females) or substance abuse
  • Smoking
  • Working hours outside 7 am - 7 pm
  • Habitual napping (>20 minutes per day on a regular basis)
  • Obliged to wake and care for family/friends (e.g. new born child etc)
  • Use of antidepressants
  • Depressed mood (Center of Epidemiologic Studies of Depression 20-item scale questionnaire)
  • Travel arrangements outside time zone within the periods of data collection
  • Travel arrangements outside time zone within period of intervention/control condition
  • Inability to adhere to a sleep hygiene intervention/sleep schedule due to time commitments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787577


Locations
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United Kingdom
Diabetes & Nutritional Sciences Division, King's College London
London, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Wendy Hall, PhD King's College London

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02787577     History of Changes
Other Study ID Numbers: SLuMBER Study 2016
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by King's College London:
Sleep Duration
Sleep Quality
Body Composition
Energy Intake
Energy Expenditure
Energy Balance
Cardiovascular Risk